PRIOR NOTICE FDA

PRIOR NOTICE FDA

Handling of an Incoming Ocean Shipment

January 31, 2009

Last Revised: May 23, 2012 4:50 PM

The original content of this Company Policy has been saved to a "legacy location" here.

This Company Policy, page, includes information about an FDA activity referred to as "Prior Notice."

An FDA web site related to this activity is HERE.

To make submissions to FDA (e.g., Food Facility Registration, Prior Notice, etc.) you must either create a new account or use an existing account.

A previously existing account has now been updated to show new "profile" information shown on this page.

As of January 31, 2009 a previous "registration" for this FDA activity, in the name of Maia Mulvena, has been changed to show the ED, Clifford Woods, as the primary account holder, with Loren C. Troescher, Founder, as a "Sub-Account" holder, both with access and control privileges.

The two accounts are shown on this FDA web site as follows:

	[Account]	vib51971	Clifford Woods Vibrant Life Burbank, California 91504 UNITED STATES
	[Subaccount]	vib61875	Loren Troescher Vibrant Life Vibrant Life LLC Canyon Country, California 91387 UNITED STATES

The Main Account ID is: vib51971

Passwords must be at least 8 characters but no more than 32, contain uppercase and lowercase letters, numbers and special characters (e.g &,%,$)

Using our standard encryption procedure, the initial password created by Karl on January 31, 2009, for the main account (Clifford Woods), was BAK34lava$

Clifford can change information for the main account, including a change in the password, etc.

The Subaccount ID is: vib61875

Password for the Subaccount, temporary: A subaccount has been created for you. For security reasons, your subaccount ID was sent in a separate notification/e-mail. The temporary password was used -- j3H@h@5r -- and changed by LCT on 2 Feb 09 to bak34LAVA$

Initial Profiles

Main account information.
First Name:	Clifford

Middle Initial:

Last Name / Surname:	Woods

Title:	Executive Director

Account Privileges:	Yes

Company Name:	Vibrant Life

SubAccount Company Name:	Vibrant Life LLC

Phone Number:	818 5581799

FAX Number:	818 5587299

E-Mail Address:	ED@oralchelation.com

Secret Question:	What is your Mother's maiden name?

Secret Answer:	jenkins

Physical Address (Business) of Account Holder
Address Line 1:	2808 North Naomi Street

Address Line 2:

City:	Burbank

State / Province / Territory:	California

Zip Code (Postal Code):	91504

Country:	UNITED STATES

Vibrant Life is registered with the FDA for access to the following systems:

Select the systems you will need to access:
FDA Unified Registration Listing Systems
Food Facility Registration
Low Acid Canned Food
Device Registration and Listing Module
Drug Facility Registration

Other FDA Systems
Prior Notice

Subaccount information.
First Name:	Loren

Middle Initial:	C

Last Name / Surname:	Troescher

Title:	Founder

Account Privileges:	Yes

Phone Number:	661 3608368

FAX Number:

E-Mail Address:	kloren@oralchelation.com

Physical Address (Business) of Account Holder
Address Line 1:	14542 Edgeview Place

Address Line 2:

City:	Canyon Country

State / Province / Territory:	California

Zip Code (Postal Code):	91387

Country:	UNITED STATES

The subaccount was successfully created. The subaccount ID is vib61875. The subaccount ID and password were sent to the account holder via e-mail or postal mail. When Loren first logs into this Subaccount, he can change his profile and his password information. Clifford can change his account information when he logs in.

Comments from MSR:

Dear Cliff,

Ever since 9/11 the import laws and regulations of USA have been continuously changing. US-FDA & Port Customs have made it mandatory that they are informed about any shipment that is arriving into USA much in advance. We have to do the same here in order to clear the shipment for export. You have to talk to your shipping agent and arrange to complete the requisite documentation with port authorities and obtain clearance for importing any consignment. You need to give us those particulars (fax copy of permission) to enable our shipping agent to clear the goods in Indian ports for export. This was earlier handled by Maia & Kimberly earlier. It looks like the format has changed again. So you may ask your shipping agent to handle this and keep everything in readiness to avoid problem while importing. There were times when VL had to pay huge penalty while importing goods and clearing in LA port.

Keep all the documentation in perfect shape and readiness. Your shipping agent will do this - but under instructions from you.

Regards,
MSR.

Information which follows was from the original research done by Karl as he found out how to re-activate the old Vibrant Life account with the FDA, and to change access and profile as shown above.

Here is help information from the Prior Notice web page:

	Welcome to the Prior Notice System Interface

function submitNewPnWelcome(jsActionName) { //alert("nihdb=" + document.NewQueryForm.nihDB.value); //if (document.NewQueryForm.queryTitle.value.length < 1) { alert('Inside submitNewPnWelcome actionName=' + jsActionName); //} else { document.pnWelcomeForm.actionName.value=jsActionName; document.pnWelcomeForm.submit(); //} }
The Prior Notice System Interface enables you to submit Prior Notices for Imported Food Articles to the Food and Drug Administration (FDA).

		Overview of how to submit a Prior Notice for Food Importation.
		Overview of New Features available in this version of the Prior Notice System Interface.
		Creating a Web Entry is the first step in creating Prior Notices. A Web Entry contains information that one or more food articles you intend to import share (e.g., arrival information). After Creating a Web Entry, create, review, and submit Prior Notices. Prior Notices include information about the Product, its Quantity and Packaging, and other related information, such as the Manufacturer or Grower/Consolidator and the Shipper.
		You must complete the Web Entry after you have submitted all Prior Notices that you are planning to submit as part of this Web Entry. This will allow U.S. Customs and Border Protection to receive the Prior Notice review decisions in time from the U.S. Food and Drug Administration (FDA) for all articles in the Web Entry. The system automatically "Completes" Web Entries with submitted Prior Notices when the Prior Notice submission timeframe elapses (see the "Complete Web Entry" Help topic).
		Use this feature to find Web Entries that you have already created.
		Use this feature to find Prior Notices that you have already created. To submit Holding Facility information for a Prior Notice submitted via PNSI by this account or another account within the same company, search for the Prior Notice and click the Submit Holding Facility button.
		To submit Holding Facility information for a Prior Notice that has been submitted via the U.S. Customs' and Border Protection (CBP) Automated Commercial System (ACS) or by another PNSI user of a different company click on the View/Submit Holding Facility button.
		Use this feature to maintain Favorite Facilities that you have already created.

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Getting Started

Welcome to the Prior Notice System Interface!

This section explains the basic information you need to know to start entering Prior Notice information for submission to the United States Food and Drug Administration (FDA).

Topics:

Prior Notice Submission Process

Basic Concepts

Web Entry

The Web Entry information is the basic data that relates to a shipment of food articles requiring Prior Notice. Creating the Web entry is the first step in the Prior Notice submission process. The Web Entry can relate to one or more food articles, each of which must have a separate confirmed Prior Notice.

Information required varies by Entry Type. The following United States Customs and Border Protection (CBP) Entry Types are subject to the Prior Notice Rule:
- Baggage
- Consumption [Note: The Prior Notice System Interface also has Consumption, Express Courier which is a subset of the Consumption Entry Type.]
- Foreign Trade Zone (FTZ) Admission
- Immediate Transportation (IT)
- Informal
- Mail (Commercial) [Note: The Prior Notice System Interface also has Mail (Non-Commercial Sender) which is a subset of the Mail Entry Type.]
- Temporary Importation under Bond (TIB)
- Transportation for Exportation (T&E) [Note: The Prior Notice System Interface also has Transportation for Exportation (T&E), Express Courier which is a subset of the Transportation for Exportation Entry Type.]
- Warehouse
The system displays an asterisk (*) to the left side of the label to indicate that the data is required for the Web Entry.
The information within a Web Entry includes an Entry Identifier (e.g., CBP Entry Number, In-bond or FTZ Number, or a system-generated number) and information about the anticipated arrival, the Submitter, Importer, and Carrier.
The Carrier should present a copy of the Web Entry Summary Confirmation to United States Bureau of Customs and Border Protection (CBP) at the Port of Arrival.

Prior Notice

A Prior Notice provides notification to the FDA about an import shipment of an article of food prior to its arrival in the United States.
A Prior Notice includes information about the product identity and facilities in its chain of custody. Examples of facilities include Manufacturer, Producer, Shipper, Owner, Ultimate Consignee, and Holding Facility. Information required in a Prior Notice varies by Entry Type. The system displays an asterisk (*) to the left side of the label to indicate that the data is required for the Prior Notice.
Anyone with knowledge of the required information may submit a Prior Notice through the FDA Prior Notice System Interface.
Filers who currently submit Entries for admissibility processing through the Automated Broker Interface (ABI) to the CBP Automated Commercial System (ACS) can continue to submit Prior Notices through that system.

Article of Food

An article is any food product, including animal feed, subject to Prior Notice.

>> Return to Getting Started

Prior Notice Submission Process

Collect Prior Notice Information. Accumulate all the information required for your Prior Notice Submission.
Create the Web Entry. The Web Entry contains information about the collective shipment. You must create a Web Entry before creating the Prior Notices associated with the Web Entry. For more information, see the Web Entries topic.
Create a Prior Notice. The Prior Notice contains information directly related to the food products imported in the shipment. A Web Entry may contain one or more Prior Notices. As you create your Prior Notice, you may set facilities that apply to other articles in the shipment as default, to avoid duplicate data entry. For example, if all food products in this shipment have the same manufacturer, you should set the manufacturer as default. You may save the Prior Notices in "Draft" status and update them later. For more information, see the Prior Notices topic.
Review and Edit the Web Entry and the First Prior Notice. Review your information and make all necessary changes. After you submit Prior Notice information to the FDA, you cannot make changes to the Prior Notice or to the Web Entry. For more information, see the Reviewing and Editing a Prior Notice topic.
Submit the Prior Notice to FDA. After the FDA receives the Prior Notice, the system displays a Confirmation Page including a Confirmation Number. For more information, see the Submitting a Prior Notice topic.
Print Prior Notice Confirmation. The Confirmation Page is your proof that you have filed a Prior Notice with the FDA. The Prior Notice Confirmation Number must accompany food carried by or otherwise accompanying an individual (1.279(f)). You may wish to print and keep a copy of each Prior Notice for your files, but presenting a copy of the Prior Notice Confirmation is not required.
Create an Additional Prior Notice. Continue to create additional Prior Notices until you have completed one for each food article in the shipment. If individual Prior Notices within the Web Entry contain similar information, select the Prior Notice that is most similar to the one you need to create, use the copy function, and then make changes as required. For more information, see the Prior Notices topic.
Review and Edit the Additional Prior Notice. After you have submitted your first Prior Notice, you may only edit information in Prior Notices you have not submitted. Make any necessary corrections and return to step E. For more information, see the Reviewing and Editing a Prior Notice topic.
Complete the Web Entry and Print the Summary Confirmation. When you have submitted all Prior Notices you intend to submit for your Web Entry, complete the Web Entry. Completing the Web Entry indicates to FDA that you are done adding Prior Notices to the Web Entry and cancels all Prior Notices in Draft status. (See the Completing a Web Entry topic.) FDA recommends printing the Web Entry Summary Confirmation for your records and to facilitate presentation of the confirmation number(s) to CBP or FDA upon arrival at the port. Note that a copy of the confirmation (with the PN Confirmation Number) must accompany any article of food carried or otherwise accompanying an individual (unless excluded under IFR § 1.277(b)(1)), and be provided to CBP or FDA upon arrival. (See the Accessing the Web Entry Summary Confirmation topic.)

If you do not Complete your Web Entry before the end of the timely submission period, based upon the mode of transportation (2 hours before arrival for Land, 4 hours before arrival for Air or Rail, or 8 hours before arrival for Water) the system will complete it automatically. If the system automatically completes your Web Entry and you need to submit additional Prior Notices for it, copy the Web Entry and continue creating and submitting Prior Notices. When you have finished all Prior Notices, make sure that you Complete the Web Entry.
Present the Summary Confirmation Information at the Port of Arrival. To facilitate presentation of the confirmation number(s) to CBP and FDA upon arrival and the passing through the Port of Arrival, the FDA and CBP suggest the Carrier provide a Copy of the Web Entry Summary Confirmation to United States Bureau of Customs and Border Protection (CBP). If you are sending your Web Entry via International Mail, you must note the Shipment Confirmation Number on your Customs Declaration Form affixed to the package.

For more information, see the Web Entries and Prior Notices topics.

>> Return to Getting Started

Getting Help

If you need to find more information about the Prior Notice Rule, FDA Product Codes, or if you need to contact FDA for Help, click on the Contact Us hyperlink in the upper right-hand corner of any page in the Prior Notice System Interface, to get information from the FDA Help Desk.

>> Return to Getting Started

_________________________

Automated Broker Interface (ABI)

Operational and Administrative System for Import Support (OASIS)

Prior Notice of Imported Foods

(Karl created an account at this last link, entering: "Loren C. Troescher, Owner, password BAK99$lava, result:

You have successfully created an account.

Your account ID is vib20537

After creating this account, Karl engaged in a series of personal eMails to the help desk at the FDA, resulting in the FDA giving us access to our old account, created by Maia Mulvena. The information in the old account was then changed, as per all the above, by Karl on January 31, 2009

Further reference to the temporarily created account by Karl has now been deleted from its previous location on this page.

Quotes from L. Ron Hubbard are copyright 1994 © by the L. Ron Hubbard Library. All rights reserved.

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